3NT endoscopy system— 510(k) K162916
Substantially Equivalent3nt Medical , Ltd.
FDA 510(k) clearance K162916 for 3NT endoscopy system, Substantially Equivalent on 2017-02-24. Applicant: 3nt Medical , Ltd.. Device class: 2.
Clearance details
- Applicant
- 3nt Medical , Ltd.
- Product code
- Code EOB
- Device class
- Class 2
- Regulation
- 21 CFR 874.4760
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rosh Ha'Ayin, IL
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More clearances from 3nt Medical , Ltd.
view allAdverse events under product code EOB
product code EOB- Malfunction
- 6,143
- Total
- 6,143
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.